Crystalloid Fluid Choice and Neurological Outcome in Patients After Subarachnoid Haemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
Patients with subarachnoid hemorrhage are prone to suffer from dysnatriemia. Evidence shows that hyponatriemia is associated with increased incidence of vasospasm, brain swelling and mortality in these patients. Patients with subarachnoid hemorrhage often require large amounts of iv fluids in order to maintain euvolemia and support cardiocirculatory function. Prior evidence shows that the type of infusion fluid significantly influences blood sodium content. Hence, this study evaluated whether the sodium content of the infusion solution impacts mortality and morbidity in patients with subarachnoid hemorrhage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients with major intra-cranial trauma
Diagnosis of an AV-malformation as the source of subarachnoid hemorrhage on the primary CT/MRI or angiography
More than 24 hours after diagnosis of subarachnoid haemorrhage as diagnosed by cerebral imaging (CT scan or MRI)
Patients with clear limitation to therapy at hospital admission (eg ICU admission for evaluation of organ donation)
Trial design
Design model
Parallel
Treatments tested in this trial
0.9% Sodium-chloride
DrugWe will compare two already established treatment protocols: the use of normal saline versus lactated Ringer's for fluid therapy in patients with subarachnoid hemorrhage.
Ringer's Lactate
DrugWe will compare two already established treatment protocols: the use of normal saline versus lactated Ringer's for fluid therapy in patients with subarachnoid hemorrhage.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: high sodium infusion fluidActive comparator 1 intervention
Group B: low sodium infusion fluidActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with clinically relevant vasospasms
Defined as new neurologic deficit requiring immediate intervention
Time frame
From ICU admission until discharge (usually within the first 21 days)Secondary outcomes
1
Number of ICU deaths
Death on the ICU
Time frame
From ICU admission until discharge (usually within the first 21 days)2
Number of In-hospital deaths
Death during hospital stay
Time frame
From hospital admission to hospital discharge (usually within the first 21 days)3
Number of severe vasospasms requiring endovascular treatment
Number of severe vasospasms requiring endovascular treatment
Time frame
From hospital admission to hospital discharge (usually within the first 21 days)4
Number of patients needing decompressive hemicraniectomy
Operative intervention needed for high intracranial pressure
Time frame
From hospital admission to hospital discharge (usually within the first 21 days)Sponsors and contacts
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Source ClinicalTrials.gov